Drug recall
Daavlin Aquex (DAAV1000)
FDA recall event 76362 · Class III · Hidrex GmbH
Key facts
| Event ID | 76362 |
|---|---|
| Recall numbers | Z-1236-2017, Z-1237-2017, Z-1238-2017 |
| Recalling firm | Hidrex GmbH |
| Product type | Devices |
| Products | Daavlin Aquex (DAAV1000), Hidrex USA DP450, Hidrex USA DVP1000 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device was reclassified from a class III device to a class II device and there are new documentation requirements. |
| Initiation date | Jan 30, 2017 |
| Report date | Mar 1, 2017 |
| Termination date | Aug 4, 2017 |
| City | Heiligenhaus |
| Country | Germany |
| FEI number | 3008642982 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: